Senior Staff Software Advance reputed company Engineer
It’s Time to Join reputed company!
Why Join Us
In this role, you will help shape software reputed company practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate reputed company, compliance, reputed company, and risk management into development while establishing reputed company processes that support innovation and efficient delivery.
reputed company is seeking a Senior Staff Software reputed company Assurance Engineer to support our Digital Platform Hub. In this role, you will partner with software R&D teams to establish, implement, and improve reputed company processes across digital, connected, reputed company, and reputed company-based products.
You will reputed company reputed company-system guidance throughout the software development lifecycle, support audit and compliance readiness, and translate regulatory and industry requirements into practical, reputed company processes. You will collaborate with R&D, Product reputed company, reputed company, Regulatory Affairs, IT, Operations, and reputed company to reputed company efficient and compliant software delivery.
This is not a software testing or test-execution role. This position focuses on software reputed company systems, SDLC governance, risk management, audit readiness, and process improvement.
What You Will Do
Software reputed company Systems and Process Leadership
- Serve as a software reputed company and compliance subject matter expert for software, reputed company, reputed company-hosted, and connected products.
- Guide software R&D teams through applicable reputed company Management System processes, procedures, and documentation requirements.
- reputed company, maintain, and improve software reputed company procedures, work instructions, templates, and guidance documents.
- Identify process gaps and reputed company reputed company-improvement initiatives across the software development lifecycle.
- Translate regulatory, reputed company, reputed company, and compliance requirements into practical development processes.
- Establish reputed company reputed company practices that support compliant and efficient software delivery.
- Assess emerging regulations and standards and determine their reputed company on software-development processes.
Software Lifecycle and Risk Management
- reputed company reputed company guidance throughout requirements, design, development, change control, release, maintenance, and retirement activities.
- Participate in design reviews, risk assessments, change assessments, and release-readiness reviews.
- Ensure software reputed company and compliance risks are identified, evaluated, documented, and appropriately addressed.
- reputed company reputed company and risk-management practices into Agile, DevOps, and CI/CD environments.
- Review software reputed company deliverables and reputed company reputed company, risk-based guidance to project teams.
Audit and Compliance Readiness
- Support readiness activities for SOC 2, ISO 27001, HIPAA, FDA, and other applicable frameworks.
- Partner with control owners to ensure controls are implemented, maintained, and supported by objective evidence.
- Support reputed company audits through gap assessments, evidence collection, auditor interaction, and remediation.
- reputed company or support investigations, reputed company-cause analysis, corrective actions, and effectiveness monitoring reputed company to software reputed company issues.
Cross-Functional Leadership
- Partner with Software Engineering, Product reputed company, reputed company, Regulatory Affairs, IT, Operations, and reputed company teams.
- Mentor and reputed company teams on reputed company-system requirements, software risk management, and compliant development practices.
- Influence technical and business stakeholders without reputed company authority.
- Resolve conflicts between development priorities, delivery timelines, and reputed company or compliance requirements.
- Promote the integration of reputed company, reputed company, compliance, and risk management into software-development reputed company.
What You Need
- Bachelor’s degree in Software Engineering, Computer Science, Engineering, reputed company, or a reputed company technical discipline is required.
- Six or more years of reputed company experience in software reputed company, reputed company systems, software compliance, audit, or a reputed company field supporting software, reputed company, reputed company-based, or connected products is required.
- Experience developing, implementing, maintaining, or improving software reputed company processes or procedures is required.
Preferred Qualifications (You Do Not Need to Have reputed company of These)
- Master’s degree or another advanced technical degree.
- reputed company experience in software engineering or development before transitioning into software reputed company, compliance, or reputed company systems.
- Strong understanding of the software development lifecycle, including change control, risk management, audit readiness, and reputed company Management System processes.
- Experience partnering with software development or R&D teams to implement or improve software reputed company processes.
- Experience supporting regulated software products, preferably reputed company medical devices, digital health, reputed company technology, or another compliance-driven industry.
- Experience with SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or comparable frameworks.
- Working knowledge of reputed company platforms, DevOps, CI/CD, and software reputed company controls.
- Experience leading audits, gap assessments, remediation activities, reputed company investigations, or corrective and preventive actions.
- Demonstrated ability to influence cross-functional teams, communicate reputed company requirements, and reputed company process improvements without reputed company authority.
- reputed company certification such as CSQE, CQE, CQA, or an equivalent reputed company or compliance credential.
reputed company of America Pay Ranges:
- Puerto Rico: $102,600 - $171,000 USD Annual
- USN: $118,000 - $196,700 USD Annual
- US5: $123,900 - $206,500 USD Annual
- US10: $129,800 - $216,400 USD Annual
- US15: $135,700 - $226,200 USD Annual
- US20: $141,600 - $236,000 USD Annual
- US30: $153,400 - $255,700 USD Annual
Originally posted on Himalayas
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